Events

Recall of Torque Limiting Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greatbatch Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73948
  • Event Risk Class
    Class 2
  • Event Number
    Z-1884-2016
  • Event Initiated Date
    2016-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145759
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    Greatbatch medical has initiated a global field recall for torque limiting devices. greatbatch identified through laboratory testing that the required sterility assurance level (sal) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the instruction for use (ifu) provided with the device.
  • Action
    Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.com.

Device

Torque Limiting Adapter
  • Model / Serial
    1000207 1001049 1001048 1000698 1000582 1000582 1001334 1001334 1002457 1002456 1002974 1002640 1003175 1003174 1003223 1003223 1003224 1003225 1003548 1003766 1003908 1004435 1004485 1004349 1004903 1005099 1004347 1005530 1005772 1005900 1009013 1008458 1009195 1009195 1009197 1009014 1009198 1009196 1009698 1009199 1009699 1009200 1009700 1011763 1010602 1012455 1012490 1013172 1013173 1013415 1013416 1013921 1013922 1514611 1614605 1714700 1953758 1953809 1953810 2124866 2073128 2116179 2141896 1953758 2150164 2157328 2209891 2302780 2302777 2302781 2302788 2362691 2407040 2407047 2407040 2407040 2898285 2898285 2898289 2971943 2904251 2919512 2938191 2978582 1004138 1004139 1004413 1004578 1004577 1004580 1004579 1005899 1005817 1009701 2324706 2920624 3092836 3092836 1006939   FC-002 FC-002 1012458 6280900001  8027435 8027436 8027434
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
  • Product Description
    Torque Limiting Adapter: || Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. || PRECIMED, Torque Limiting Adaptor, Non Sterile.. || Customer Number/Model: || 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, || 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, || MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA